UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028943 |
|---|---|
| Receipt number | R000033097 |
| Scientific Title | Evaluation of the extraction site location in laparoscopic colorectal surgery midline incision vs off midline incision Randomized controlled study |
| Date of disclosure of the study information | 2017/08/31 |
| Last modified on | 2022/07/18 21:04:37 |
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Basic information
Public title
Evaluation of the extraction site location in laparoscopic colorectal surgery midline incision vs off midline incision Randomized controlled study
Acronym
Evaluation of the extraction site location in laparoscopic colorectal surgery RCT
Scientific Title
Evaluation of the extraction site location in laparoscopic colorectal surgery midline incision vs off midline incision Randomized controlled study
Scientific Title:Acronym
Evaluation of the extraction site location in laparoscopic colorectal surgery RCT
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will examine the location of small incision at laparoscopically assisted surgery by comparative test of random assignment for patients with colon cancer who can be expected to have curability by laparoscopic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will evaluate the small incision in the first year after surgery using postoperative wound evaluation POSAS (patient and observer scar assessment scale).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
midline incision
Extend the trocar hole in the umbilicus. Closure wound is suturing the white line and the peritoneum all together, suturing closure of the skin, compressing the cotton ball into the umbilicus.
Interventions/Control_2
off midline incision
Extend the transrectus trocarshole. Closure wound closes the skin by suturing the peritoneum and the posterior sheath, suturing the rectus abdominis anterior sheath and suturing the skin.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
For anatomical colon cancer cases from ascending colon, descending colon, sigmoid colon and rectosigmoid colon cancer cases, 100 cases that satisfy the following conditions and were able to acquire consent in the document are targeted.
Eligibility criteria
1 tumor is not more than 5 cm
2 There is no history of laparotomy
3 There is no ileus symptom
Key exclusion criteria
1 Psychosis or psychiatric symptoms are merged, and it is judged that participation in the examination is difficult.
2 Continuous systemic administration (ingestion or intravenous) of steroid drugs.
3 During treatment with insulin, or with poorly controlled diabetes mellitus.
4 Combined respiratory diseases requiring sustained oxygen administration.
5 There is no history of lower limb thrombosis.
6 Do not limit the concomitant medication.
7 When other medical doctor judges that participation in this examination is inappropriate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katusnari Takifuji |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama, JAPAN
TEL
073-441-0613
hiwa@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Iwamoto |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama, JAPAN
TEL
073-441-0613
Homepage URL
hiwa@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033097
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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